This study is in progress, not accepting new patients

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

a study on Hypertriglyceridemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

Details

This is a multi-center, randomized, double-blind, placebo-controlled study in up to approximately 540 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.

Keywords

Severe Hypertriglyceridemia, ISIS 678354, Fasting Triglycerides, Apolipoprotein C-III, Very Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein-Cholesterol, Non-High-Density Lipoprotein-Cholesterol, Olezarsen, Hypertriglyceridemia

Eligibility

You can join if…

Open to people ages 18 years and up

  • Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
  • Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.

You CAN'T join if...

  • Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
  • Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
  • Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
  • Estimated GFR < 30 mL/min/1.73 m2

Locations

  • University of California, San Diego (UCSD)
    La Jolla California 92037 United States
  • America Clinical Trials
    Tarzana California 91356 United States
  • Diabetes/Lipid Management & Research Center
    Huntington Beach California 92648 United States
  • LA Universal Research Center, Inc.
    Los Angeles California 90057 United States
  • Velocity Clinical Research
    Chula Vista California 91911 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ionis Pharmaceuticals, Inc.
ID
NCT05079919
Phase
Phase 3 Hypertriglyceridemia Research Study
Study Type
Interventional
Participants
About 617 people participating
Last Updated